Radiation-Emitting Products

Facility Responsibility Regarding Inspection Observation(s) Follow-up

With regard to inspection observations the most responsible individual is the person at the facility who has the duty and power to make major decisions regarding corrective action and general operations. Major decisions can include the power to approve the purchase of expensive equipment (e.g. a new x-ray system), hire and fire personnel (e.g., interpreting physicians, radiologic technologists or medical physicists), and order as well as assure the implementation of significant quality assurance changes at the facility.

As an example, the chairperson of a radiology department at a facility may report to a medical director or an administrator. However, if the chairperson of the department has the power to make the types of decisions mentioned above, the chairperson is considered the most responsible individual connected with the observation. In this particular example, if serious observations were made (listed in Attachment D of Compliance Program 7382.014, Mammography Facility Inspections, under level 1), the FDA District could address a Warning Letter would be addressed to the chairperson of the department. The FDA District could also send copies of the Warning Letter to the addressee's superior (e.g. medical director) and to the highest known official in the organization (e.g. administrator or chief executive officer).

For MQSA inspections, the name and title recorded in the block for "responsible individual for compliance" would be the most responsible individual connected with the observation as described above. However, the inspection record must also include the name, title, and address of the highest official in the corporation, firm, facility, or organization; this information should be identified in the Remarks section of the Compliance Contact Data screen.

Highest Official for Facility – There may be additional people who should get copies of the Warning Letters (i.e., the corporation president or hospital administrator might get a copy of the Warning Letter sent to the chief of radiology). In those facilities where the most responsible individual for mammography, as defined above, is different than the highest official in the corporation, organization or facility, please indicate the name, title, and mailing address of this individual(s) in the Remarks section of the Compliance Contact Data screen in the inspection software.